Formulation Development and In Vitro Evaluation of Immediate Release Fenofibrate Pellets
Amtun Noor1*, P.R.Sathesh Babu1, P. Aravind2
1Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy, Hyderabad, India.
2Nosch labs private limited, Prashanthi Nagar, Kukatpally, Hyderabad.
The present study was aimed to formulate and evaluate immediate release fenofibrate pellets using pan coater. Fenofibrate, anti lipidemic drug, being water insoluble with a half life of 22.1 h suitable to develop immediate release pellets for the treatment of primary hypercholesterolemia. Eight formulations (F1-F8) of fenofibrate pellets were prepared using a combination of PVPK30 as binder and starch as a disintegrant. The prepared pellets were subjected to micrometric properties and In vitro drug release studies. The optimized formulation, F8, showed 99.1% drug release in 30 min. Scanning electron microscopy (SEM) studies showed that the prepared pellets are spherical in shape. The release profile for optimized formulation (F8) was comparable and found higher release than the marketed formulation (LIPICARD) for fenofibrate. The mathematical model was built on the hypotheses that drug diffusion and drug dissolution in the release environment are the key phenomena affecting drug release kinetics and drug release was found to be followed first order with dissolution mechanism.
Fenofibrate; pelletization; immediate release; PVPK30.